MAUDE Adverse Event Report: INSTRUMENTATION LABORATORY ACL TOP 500 CTS; ACL TOP, PRODUCT CODE: GKP

Model Number 2800-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

An investigation was conducted that included a review of the instrument clot curves.All aptt results illustrated well-formed curve formation, with appropriate clotting times detected and no concerning errors or warnings.The conclusion is that the values obtained on the acl top 500 cts were appropriately determined by the analyzer and the instrument was performing as intended.Based on the above, there was no indication of an instrument malfunction and no remedial action is needed.

Event Description

A customer reported that their acl top 500 cts generated an erroneous aptt result (36.9 seconds) using hemosil synthasil.A patient was administered an increased dose of heparin based on this erroneous aptt result.Subsequently, another sample was drawn from the same patient (approximately 3 hours later) and it reported an aptt result of > 200.The heparin administration was stopped and the customer indicated that the patient's aptt result was brought back into the therapeutic range.There were no further reports of clinical implications for the patient.

• Brand Name: ACL TOP 500 CTS
• Type of Device: ACL TOP, PRODUCT CODE: GKP
• Manufacturer (Section D): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer (Section G): INSTRUMENTATION LABORATORY; 180 hartwell road; bedford MA 01730
• Manufacturer Contact: reba daoust ; 180 hartwell road; bedford, MA 01730 ; 7818614597
• MDR Report Key: 8024101
• MDR Text Key: 125650474
• Report Number: 1217183-2018-00009
• Device Sequence Number: 1
• Product Code: GKP
• UDI-Device Identifier: 08426950453499
• UDI-Public: 08426950453499
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2800-40
• Device Catalogue Number: 00000280040
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other